Inflatable in-vivo capsule endoscope with magnetic guide

ABSTRACT

An inflatable in-vivo capsule endoscope and method of operation is provided. The inflatable in-vivo capsule endoscope may include a sensing device for capturing in-vivo images and one or more permanent magnets for magnetically guiding the endoscope, housed interior to a capsule-shaped body. The inflatable in-vivo capsule endoscope may include an inflatable buoy attached externally to the capsule-shaped body. An inflation device may inflate the in-vivo capsule endoscope to reduce its specific gravity by injecting gas into the inflatable buoy, such that when the inflatable buoy is injected with an above threshold volume of gas, the inflatable in-vivo capsule endoscope floats in liquid. The inflatable in-vivo capsule endoscope may be magnetically guided via its permanent magnets when exposed to an externally generated magnetic field. A reduced magnetic field strength and external magnet size may be used to magnetically navigate an inflated capsule floating in liquid than a conventional uninflated capsule.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 62/911,688, filed Oct. 7, 2019, which is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

Embodiments of the invention relate to an ingestible or in-vivo capsuleendoscope configured to traverse and image at least a portion of thegastro-intestinal (GI) tract. More particularly, some embodiments relateto an ingestible capsule endoscope that has a permanent magnetic dipolemoment configured to be magnetically guided while inside a human by amagnetic field generated by a magnetic device positioned external to thehuman body.

BACKGROUND OF THE INVENTION

Conventional in-vivo capsule endoscopes are guided magnetically to movethrough the human body. These capsules contain magnets, batteries,cameras, and other electronics that are relatively heavier than, andthus sink in, liquid. So, when the capsule passes into a liquid-filledcavity, such as the stomach, the capsule generally sinks to the bottomof the cavity.

Once sunk, the capsule rests on the cavity floor, and needs a relativelystrong magnetic force, e.g., 0.006 Newtons (N)-0.06N, to overcome forcesof friction and drag between the capsule and the cavity floor in orderto be moved. Generally, conventional systems require a large bed ofmagnets to create a magnetic field strong enough to magnetically turn ormove the sunken capsule. Such magnets typically occupy an entire roomand are not meant to be moved, limiting access and portability to thosein need. Additionally, when the capsule sinks, its field of view isgenerally obstructed by the cavity walls and floor, blocking objects ofinterest in images captured by the capsule.

Accordingly, there is a need in the art for a more efficient system tomagnetically guide in-vivo capsule endoscopes.

SUMMARY OF EMBODIMENTS OF THE INVENTION

To solve the aforementioned problems in the art, embodiments of theinvention provide an inflatable in-vivo capsule endoscope system thatcauses the capsule to float in liquid. When floating, the capsule issuspended in liquid above the floor of the stomach or otherliquid-filled cavity. This buoyancy makes the capsule significantlyeasier to move magnetically by reducing forces of friction or drag e.g.,between the capsule and the cavity walls. A floating capsule requires asignificantly weaker magnetic force, e.g., 0.0006 Newtons (N)-0.006N, toguide the capsule than does a sunken capsule (e.g., a ten-fold or orderof magnitude reduction). Such a magnetic field can be generated by asmaller magnet than in conventional systems. In some embodiments, themagnet may be small enough to be handheld or portable, makingmagnetically guided capsule endoscopy accessible to a wider range ofpatients.

Additionally, because a floating capsule is spaced from the cavityfloor, embodiments of the invention may reduce or eliminate obstructionsor occlusions by the cavity walls or floor to the capsule imager's fieldof view. Accordingly, embodiments of the invention may improve thevisibility of objects of interest in images generated by the floatingcapsule endoscope, as compared to a conventional sunken capsuleendoscope. In some embodiments, the level of inflation may be adjustedor tuned, such that, the capsule may float to a height below the liquidsurface to prevent refraction or glare at the surface to further improveimage quality.

In an embodiment of the invention, an inflatable in-vivo capsuleendoscope is provided comprising a capsule-shaped body, a sensing devicefor capturing in-vivo images housed interior to the capsule-shaped body,an inflatable buoy external to the capsule-shaped body, and one or morepermanent magnets housed interior to the capsule-shaped body. Aninflation device may be configured to inflate the in-vivo capsuleendoscope by injecting gas into the inflatable buoy to reduce thespecific gravity of the in-vivo capsule endoscope. When the inflatablebuoy is injected with an above threshold volume of gas, the inflatablein-vivo capsule endoscope is configured to float in liquid. The one ormore permanent magnets have a permanent magnetic moment for magneticallyguiding the inflatable in-vivo capsule endoscope when exposed to anexternally generated magnetic field.

In an embodiment of the invention, a method of operating an inflatablein-vivo capsule endoscope is provided. An inflatable in-vivo capsuleendoscope may be introduced in an uninflated state into a cavitycomprising liquid inside an organism. The capsule endoscope may comprisea capsule-shaped body, an inflatable buoy external to the capsule-shapedbody, and a sensing device for capturing in-vivo images housed interiorto the capsule-shaped body. An inflation device may be activated toinflate the inflatable buoy by injecting an above threshold volume ofgas into the inflatable buoy to reduce the specific gravity of thein-vivo capsule endoscope, such that, the inflatable in-vivo capsuleendoscope floats in the liquid cavity. The floating in-vivo capsuleendoscope may be magnetically navigated by exposing one or morepermanent magnets housed interior to the capsule-shaped body having apermanent magnetic dipole moment to an externally generated magneticfield that magnetically guides the inflatable in-vivo capsule endoscope.

BRIEF DESCRIPTION OF THE DRAWINGS

The subject matter regarded as the invention is particularly pointed outand distinctly claimed in the concluding portion of the specification.The invention, however, both as to organization and method of operation,together with objects, features, and advantages thereof, may best beunderstood by reference to the following detailed description when readwith the accompanying drawings in which:

FIG. 1 is a schematic illustration of an inflatable in-vivo capsuleendoscope, in an uninflated state (left image) and an inflated state(right image), according to an embodiment of the invention;

FIGS. 2 and 3 are schematic illustrations of an inflatable in-vivocapsule endoscope in a cavity of an organism in an uninflated state(FIG. 2) and an inflated state (FIG. 3), according to an embodiment ofthe invention;

FIG. 4 is a schematic illustration of an exploded view of an inflatablein-vivo capsule endoscope and components thereof, according to anembodiment of the invention;

FIG. 5 is a schematic illustration of an external magnetic controlsystem, according to an embodiment of the invention;

FIG. 6 is a schematic illustration of a tethered system for attachingin-vivo buoy to an ex-vivo inflation device via an elongated tether,according to an embodiment of the invention;

FIG. 7 is a schematic illustration of a tether for attaching in-vivobuoy to ex-vivo inflation device, according to an embodiment of theinvention;

FIGS. 8-11 are schematic illustrations of a “balloon expansion” typebuoy that attaches to the capsule-shaped body by adhesion, according toan embodiment of the invention;

FIGS. 12-14 are schematic illustrations of a “cup expansion” type buoythat attaches to the capsule-shaped body by elastic tension, accordingto an embodiment of the invention;

FIGS. 15-16 are schematic illustrations of a radially asymmetricinflation buoy, according to an embodiment of the invention;

FIGS. 17-18 are schematic illustrations of a radially and longitudinallyasymmetric inflation buoy, according to an embodiment of the invention;

FIG. 19 is a schematic illustration of an inflation buoy with acorkscrew-shaped outer surface, according to an embodiment of theinvention;

FIG. 20 is a schematic illustration an inflatable in-vivo capsuleendoscope with a corkscrew-shaped inflation buoy in an uninflated state(left image) and an inflated state (right image), according to anembodiment of the invention;

FIG. 21 is a schematic illustration of a tethered system for attaching acorkscrew-shaped inflation buoy to an ex-vivo inflation device via anelongated tether, according to an embodiment of the invention;

FIG. 22 is a schematic illustration of an exploded view of acorkscrew-shaped inflatable in-vivo capsule endoscope and componentsthereof including a diametrically polarized magnet, according to anembodiment of the invention;

FIG. 23 is a schematic illustration of an uninflated corkscrew-shapedcapsule endoscope in a narrow channel that obstructs the capsule's fieldof view, according to an embodiment of the invention;

FIG. 24 is a schematic illustration an inflated corkscrew-shaped capsuleendoscope that widens the channel to increase the capsule's field ofview, according to an embodiment of the invention;

FIG. 25 is a schematic illustration of an uninflated corkscrew-shapedbuoy with an elastic bladder, according to an embodiment of theinvention;

FIG. 26 is a schematic illustration a capsule endoscope travellingthrough a narrow channel with an uninflated elastic corkscrew buoy (topimage) and an inflated elastic corkscrew buoy (bottom image), accordingto an embodiment of the invention;

FIG. 27 is a schematic illustration of a relationship between thedirection of rotation of a corkscrew-shaped capsule endoscope and thedirection of translational propulsion of the corkscrew-shaped capsuleendoscope, according to an embodiment of the invention;

FIG. 28 is a schematic illustration of a magnetically releasableconnection between a tether and an in-vivo capsule endoscope, accordingto an embodiment of the invention;

FIG. 29 is a schematic illustration of an autonomous (untethered)capsule endoscope comprising an in-vivo buoy and an in-vivo inflationdevice, according to an embodiment of the invention;

FIG. 30 is a schematic illustration an autonomous capsule endoscopecomprising an adhesive coating for adhering a corkscrew-shaped elasticbladder, according to an embodiment of the invention;

FIG. 31 is a schematic illustration of an autonomous capsule endoscopecomprising an uninflated elastic corkscrew buoy (left image) and aninflated elastic corkscrew buoy (right image), according to anembodiment of the invention;

FIG. 32 is a schematic illustration of an autonomous capsule endoscopecomprising a hole for transporting gas from an internal inflation deviceto an external inflation buoy, according to an embodiment of theinvention;

FIG. 33 is a schematic illustration of an exploded view of abi-directional in-vivo capsule endoscope with a two-sided sensingdevice, according to an embodiment of the invention;

FIG. 34 is a schematic illustration of a tethered in-vivo buoy toinflate the bi-directional in-vivo capsule endoscope via an ex-vivoinflation device, according to an embodiment of the invention;

FIG. 35 is a schematic illustration of an uninflated tethered in-vivobuoy encapsulating the center trunk of the bi-directional in-vivocapsule endoscope, according to an embodiment of the invention;

FIG. 36 is a schematic illustration of an inflatable bi-directionalin-vivo capsule endoscope encapsulated by the tethered in-vivo buoy in acavity of an organism in an uninflated state, according to an embodimentof the invention;

FIG. 37 is a schematic illustration of an inflated tethered in-vivo buoyencapsulating the center trunk of the bi-directional in-vivo capsuleendoscope, according to an embodiment of the invention;

FIG. 38 is a schematic illustration of an inflatable bi-directionalin-vivo capsule endoscope encapsulated by the tethered in-vivo buoy in acavity of an organism in an inflated state, according to an embodimentof the invention;

FIG. 39 is a schematic illustration of an exploded view of an autonomous(untethered) bi-directional in-vivo capsule endoscope comprising aninternal inflation device and a hole for transporting gas to an externalinflation buoy, according to an embodiment of the invention;

FIGS. 40-41 are schematic illustrations of the autonomous bi-directionalin-vivo capsule endoscope that is inflatable by a “cup expansion” typebuoy, according to an embodiment of the invention;

FIGS. 42 and 43 are schematic illustrations of the autonomous inflatablebi-directional in-vivo capsule endoscope in a cavity of an organism inan uninflated state (FIG. 42) and an inflated state (FIG. 43), accordingto an embodiment of the invention; and

FIG. 44 is a flowchart of a method of operating an inflatable in-vivocapsule endoscope, according to an embodiment of the invention.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity. Further, where consideredappropriate, reference numerals may be repeated among the figures toindicate corresponding or analogous elements.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Reference is made to FIG. 1, which schematically illustrates aninflatable in-vivo capsule endoscope 100 in an uninflated state (leftimage) and an inflated state (right image), according to an embodimentof the invention. Inflatable in-vivo capsule endoscope 100 may have acapsule-shaped body 104 and an inflatable buoy 102, externally attachedto capsule-shaped body 104. Inflatable buoy 102 is a flotation device,which when inflated by an inflation device (e.g., inflation devicesurface 112 of FIG. 6) injecting an above threshold volume or pressureof gas into a bladder of the inflatable buoy 102, reduces the capsule'soverall density (or specific gravity with respect to water), such that,inflated capsule 100 floats in liquid.

Capsule 100 may also have one or more permanent magnets 124 (e.g., asshown in FIG. 4) housed interior to the capsule-shaped body 104 having apermanent magnetic dipole moment. Permanent magnets 124 allow capsuleendoscope 100 to be magnetically guided when exposed to a magnetic fieldgenerated by an external magnet control system 126 (e.g., as shown inFIG. 5).

Reference is made to FIGS. 2 and 3, which schematically illustrateinflatable in-vivo capsule endoscope 100 in a cavity of an organism inan uninflated state (FIG. 2) and in an inflated state (FIG. 3),according to an embodiment of the invention. Inflation lifts capsuleendoscope 100 from a sunken state, in which it contacts (hassubstantially zero or negligible distance from) the cavity walls orfloor in FIG. 2, to a floating state, in which it is spaced (at anon-zero or relatively greater distance) from the cavity floor in FIG.3. In some embodiments, inflated capsule 100 may float based solely onthe buoyant lift force generated by inflating buoy 102 (e.g., byreducing its density to be less than or equal to the density of water,or reducing its specific gravity with respect to water to be less thanor equal to 1). In other embodiments, inflated capsule 100 may floatbased on a combination of the buoyant lift force (e.g., caused by areduced capsule density, though still greater than water density) and amagnetic lift force, which together counteract the gravitational sinkingforce. Buoy 102 may be inflated with gas, such as air, carbon dioxide,nitrogen, or other substances such as foam, oil, or other gaseous orliquid substances or mixtures that have a lower density than water.

In some embodiments, capsule endoscope 100 may be connected to adeflation device (the same “dual-purpose” inflation-deflation device 112or a different device) configured to deflate buoy 102 by expelling avolume or pressure of gas therefrom. Deflation device may thus increasethe density or specific gravity of the in-vivo capsule endoscope so thatthe inflatable in-vivo capsule endoscope 100 sinks in liquid. In someembodiments, the capsule 100 may expelling a volume of gas to sink tothe cavity floor or float at a predefined height below the liquidsurface. In some embodiments, the capsule 100 may be sunk solely bydeflating the device, or in combination with magnetic forces. In oneexample, the deflation device may increase the capsule 100 density to begreater than the density of water, or increase its specific gravity withrespect to water to be greater than 1. In one embodiment, gas may beexpelled by opening a (resealable or non-resealable) hole in the buoy,such that no separate device is used.

In some embodiments, the degree of inflation may be tuned or adjusted sothat the capsule floats at various depths relative to the liquid surface(see e.g., FIGS. 16 and 18). Inflation device 112 may inject or expelgas to a desired volume or pressure to (automatically or manually) tunethe flotation height level of the inflatable in-vivo capsule endoscoperelative to the height level of the liquid. For example, to avoiddistortions in the images cause by refraction at the liquid surface,buoy 102 may be inflated by a volume or pressure of gas so that capsule100 floats to a liquid level that is sufficiently high while remainingcompletely submerged (see e.g., the middle height of the capsule inFIGS. 16 and 18).

Buoy 102 may be integral, fitted, or attached to an outer surface of acapsule-shaped body 104. Buoy 102 may have various sizes and shapes,such as, concave, cup-shaped, U-shaped cross-section, torus-shaped (wheninflated) and cylindrical-shaped (when deflated), spherical,ellipsoidal, etc. Buoy 102 may also be positioned along variouslocations of capsule-shaped body 104, such as, surrounding the capsule'scenter of mass, encapsulating a minimal capsule surface area to securelyattach (e.g., near an edge of the capsule, maximally spaced from thecapsule's center of mass), encapsulating a maximum capsule surface areawhile avoiding occluding the sensing device (e.g., wrapping the entirecapsule body, except the sensing device window), encapsulating anypercentage of the capsule surface area, etc. Capsule-shaped body 104 mayhouse the sensing device for capturing in-vivo images behind atransparent window or portion of the outer capsule surface 108. In oneembodiment, buoy 102 may surround or encapsulate a portion of the outercapsule surface 106 such that it does not block or occlude thetransparent portion of the outer capsule surface 108 (e.g., outside ofthe field of view of the sensing device). For a unidirectional orone-sided sensing device (e.g., with a camera system at only onelongitudinal end of the capsule, e.g., as shown in FIG. 4), buoy 102 mayhave a concave shape or a U-shaped cross-section that surrounds thecapsule's side walls and end 106 (e.g., as shown in FIG. 1), leaving thesensing device end 108 unobstructed. For a bidirectional or two-sidedsensing device (e.g., with two camera systems at the two respectiveopposite longitudinal ends of the capsule) as shown in FIGS. 33-43, buoy102 may have a torus, ring, or cylindrical shape to cradle orencapsulate the capsule's longitudinal center, but not block the sensingdevices at either longitudinal end of the capsule. In anotherembodiment, buoy 102 may substantially transparent and may partially orfully overlap or cover the sensing device's field of view. A fullyoverlapping buoy 102 may be ellipsoidal or capsule shaped.

After imaging the stomach or other liquid-filled cavities in buoy's 102inflated state, buoy 102 may be deflated to return the capsule to apartially or fully uninflated state, so that it can fit through smallerchannels (e.g., either to be retracted backwards through the esophagusvia a tether or to continue to progress forwards autonomously throughthe GI tract).

Reference is made to FIG. 4, which schematically illustrates an explodedview of inflatable in-vivo capsule endoscope 100 and components thereof,e.g., housed internal to capsule-shaped body 104, according to anembodiment of the invention. Capsule-shaped body 104 may have alongitudinal axis 111 along its longest length and a radial axis 121along a diameter of its circular cross-section. Capsule-shaped body 104may have two concave shells or hemispheres at opposite ends of itslongitudinal axis 111. At one end of its longitudinal axis 111,capsule-shaped body 104 may have a shell 108 that is a transparentwindow for housing its sensing device 128. Sensing device 128 maycomprise one or more image sensor(s), light source(s) (e.g., lightemitting diodes (LEDs)), lens(es), for capturing in-vivo images, alongwith associated processing circuit board(s) for processing, storing,and/or sending image data. At the opposite end of its longitudinal axis111, capsule-shaped body 104 may have a shell 106 that is eithertransparent (in a dual-camera endoscope) or opaque (in a single-cameraendoscope). Capsule-shaped body 104 may also house one or more permanentmagnet(s) 124 having a permanent magnetic dipole (e.g., North-South).Permanent magnets 124 allow capsule endoscope 100 to be magneticallyguided when exposed to a magnetic field generated by one or moreexternal magnets 126 (e.g., as shown in FIG. 5). Capsule-shaped body 104may also house a wireless communication system 122 comprising a wireless(e.g., radio frequency (RF)) processing board and an antenna forwirelessly transmitting and receiving information to/from a remotedevice or controller. Wireless communication system 122 may transmitin-vivo information, such as, in-vivo image data captured by sensingdevice 128, buoy 102 values or parameters such as pressure or gasvolume, magnetic field information for interacting with and beingcontrolled by external magnet control system 126, and/or other sensoryfeedback, e.g., in-vivo conditions such as temperature, pressure, pH,etc. Wireless communication system 122 may receive commands or controlinformation from an external device, such as, inflation or deflationactivation commands for an autonomous in-vivo inflation device 112and/or image capture commands or parameters. Capsule-shaped body 104 mayalso house one or more batteries or a power supply 132 to power theendoscope 100 components.

Reference is made to FIG. 5, which schematically illustrates an externalmagnetic control system 126, according to an embodiment of theinvention. External magnetic control system 126 may generate a magneticfield to guide capsule endoscope 100 via one or more permanent magnet(s)124 contained in capsule endoscope 100. External magnetic control system126 includes fixtures adapted for horizontal and vertical positioning ofone or more external permanent magnet(s) 134 by the use of verticallyand horizontally adjustable mechanisms and an adjustable base. Externalmagnetic control system 126 has freedom of movement along two axes tomove capsule endoscope 100 in three dimensions. Details of the mechanicsand operation of external magnetic control system 126 may be described,for example, in U.S. Patent Application Publication No. 2015/0380140,the entirety of which is hereby incorporated by reference.

When capsule endoscope 100 is inflated and floating in liquid, itsbuoyancy makes the capsule significantly easier to move magnetically.Accordingly, external magnetic control system 126 can be significantlysmaller, and its magnetic field can have significantly smallermagnitude, than is used in conventional external capsule-guiding magnetsystems. For example, external permanent magnet(s) 134 may have amagnetic moment M that is approximately 75 A/cm² (significantly smallerthan the 2500 A/cm², which would conventionally be used for comparablemotion if the capsule was uninflated) and a diameter of 5 cm(significantly smaller than the 16 cm, which would conventionally beused for comparable motion if the capsule was uninflated). In someembodiments, external magnetic control system 126 may be small enough tobe a handheld or portable device.

Inflatable in-vivo capsule endoscope 100 may be deployed in a tetheredsystem (e.g., as shown in FIGS. 2-3, 6-21, 23-26, and 28) or anautonomous (untethered) system (e.g., as shown in FIGS. 29-32). It maybe appreciated that details of capsule endoscope 100 described in thecontext of a tethered system also apply to the context of an autonomous(untethered) system (and vice versa), unless specifically part of, orreliant upon, the tether or autonomous inflating components orfunctionalities.

Reference is made to FIG. 6, which schematically illustrates a tetheredsystem for attaching in-vivo buoy 102 to an ex-vivo inflation device 112via an elongated tether 110, according to an embodiment of theinvention. Tether 110 may traverse a portion of the GI tract of theorganism and may connect ex-vivo inflation device 112 (positionedoutside of an organism) to the in-vivo inflatable buoy 102 (positionedinside of the organism) when inflating buoy 102. Ex-vivo inflationdevice 112 (on the end of tether 110 opposite capsule 100) may comprisea syringe, air pump, air compressor, chemical gas reactor, and/or liquidinjection pump, tank, or rubber bulb. Inflation device 112 may adjustthe air pressure or volume in buoy 102, adjust the flotation height orlevel relative to the water level, and/or adjust the pressure or size ofa corkscrew-shaped buoy to fit variable sized channels, such as theesophagus or small bowel.

Reference is made to FIG. 7, which schematically illustrates a tether110 for attaching in-vivo buoy 102 to ex-vivo inflation device 112,according to an embodiment of the invention. Tether 110 may have anextension tube 114 comprising a first end 116 that connects to inflationdevice 112 and a second end 118 that connects to buoy 102. Extensiontube 114 may be an elongated air-tight channel to transport gas frominflation device 112 to buoy 102 (for inflation) and/or extract orsuction gas from buoy 102 to a deflation device (the same or differentas inflation device 112) (for deflation). Tether 110 may have a fixedlength or retractable (variable length) extension tube 114. When fullyextended, tether 110 may span a distance at least long enough to stretchfrom outside of an organism's mouth to inside of a target channel orcavity inside the organism, such as, the stomach. The second end 118connecting tether 110 and buoy 102 may be permanently attached (e.g.,glued or affixed such that separation may break or damage the system orits components) or may be releasable (e.g., detachable by air pressureabove a threshold volume or force, or by magnetic force, withoutbreaking or damaging the system or its components). An example of amagnetically releasable second end 118 connecting tether 110 and buoy102 is described in reference to FIG. 28.

Reference is made to FIGS. 8-14, which schematically illustrate varioustypes of inflatable buoys 102, according to an embodiment of theinvention. Inflatable buoy 102 may have an air-tight bladder includingone or more membranes that seal to hold gas. Inflatable buoy 102 mayhave an inflation/deflation port through which gas flows.Inflation/deflation port may be part of (or connected to) elongated tube114 in a tether system or a hole 120 in an autonomous (untethered)system. Inflatable buoy 102 may connect to capsule-shaped body 104 by asealant (e.g., adhesive) or elastic tension. In one embodiment of asealant connection shown in FIGS. 8-11, buoy 102 may inflate by “balloonexpansion,” wherein two layers of membrane of buoy 102 form an enclosedbladder. The two layers of membrane are relatively thinly spaced andcomprise tight elastic material, forming an elastic seal withcapsule-shaped body 104. The balloon expansion buoy 102 may inflaterelatively evenly throughout the bladder. In one embodiment of anelastic connection shown in FIGS. 12-14, buoy 102 may inflate by “cupexpansion,” wherein a bladder is formed by sealing a one layer membraneof buoy 102 to the outer surface of capsule-shaped body 104 e.g., via anadhesive. The cup expansion bladder may inflate more towards the backend 106 of the capsule, thus forming a cup shaped bladder, leaving thefront end sealed. Although specific buoy dimensions are shown in thefigures, those dimensions are only shown as examples and otherdimensions may be used. The dimensions of the bladders may be made tomodified to fit a capsule device of any size or shape.

Reference is made to FIGS. 15-18, which schematically illustrate aninflation buoy 102 positioned asymmetrically (or that inflatesasymmetrically) relative to a radial axis 121, according to anembodiment of the invention. An asymmetric inflation buoy 102 may havean end that rises to a relatively higher liquid level compared to therest of the capsule to orient the capsule-shaped body 104 (e.g.,top-up), and thus the image field of view. Because the images arecollected in a righted field of view, image processing need notre-orient the images (or may reduce re-orientation processing) to speedup image processing. In FIGS. 15-16, inflation buoy 102 is asymmetricabout radial axis 121, but symmetric or centered about itslongitudinally axis 111. Thus, when inflated, capsule 100 has apredefined highest radial position, but floats level aboutlongitudinally axis 111. In FIGS. 17-18, inflation buoy 102 isasymmetric about both its radial axis 121 and its longitudinally axis111. Thus, when inflated, capsule 100 has a predefined highest radialand longitudinal positions.

Reference is made to FIGS. 19-21, 23-27 and 30-31, which schematicallyillustrate an inflation buoy 102 with a corkscrew-shaped outer surface,according to an embodiment of the invention. Corkscrew-shaped buoy 102has a spiral threading protruding along the outer-surface of the buoy.The spiral threading may rotate clockwise or counterclockwise from afirst longitudinal end to an opposite longitudinal end of the capsule(or a portion thereof). Corkscrew-shaped buoy 102 may be implemented ina tethered system (e.g., as shown in FIGS. 19-21 and 23-27) or anautonomous (untethered) system (e.g., as shown in FIGS. 30-31). Externalmagnet control system 126 may exert a magnetic force on the capsule'sinternal permanent magnet(s) 124 to guide capsule endoscope 100 througha channel, such that when buoy 102 is inflated, the spiral threadingpropels inflatable in-vivo capsule endoscope 100 forward or backwards byrotating in a spiral motion.

Reference is made to FIG. 27, which schematically illustrates an examplerelationship between the direction of rotation of the spiralingcorkscrew-shaped capsule endoscope 100 and the direction oftranslational propulsion of capsule endoscope 100, according to anembodiment of the invention. According to the example configurationshown in FIG. 27, the upper left drawing illustrates the externalcontrol magnet and the bottom left drawing illustrates the magnet insideof the capsule. The rotation of the fixed magnet inside the capsule maybe opposite to the direction of the external magnet. When using aclockwise threading, a clockwise rotation of the capsule(counter-clockwise rotation of the external magnet) will propel capsuleendoscope 100 forward (in a direction into the figure), and acounterclockwise rotation of the capsule (clockwise rotation of theexternal magnet) will cause the capsule endoscope 100 to move backwards(in a direction out of the figure). Opposite directions of motion may beachieved using a counterclockwise threading. Other directionalrelationships may also be used. For example, the direction of threadingmay be inverted such that the corkscrew-shaped surface may propelcapsule endoscope 100 forwards when rotating in a clockwise rotationaldirection and backwards when rotating in an opposite counterclockwiserotational direction.

Permanent magnet(s) 124 diametrically centered about radial axis 121(e.g., as shown in FIG. 4) cause external magnets 126 to translatecapsule endoscope 100 along the direction of longitudinal axis 111.Additionally or alternatively, as shown in FIG. 22, corkscrew-shapedcapsule endoscope 100 may have a diametrically polarized magnet 130(polarized in a diametric direction) having a position and/or dipolethat is diametrically asymmetric with respect to radial axis 121 (alonga circular cross-section of the capsule-shaped body) so that externalmagnets 126 rotate capsule endoscope 100 about its longitudinal axis111, causing a spiraling or spinning force that further drives thecapsule in a corkscrew-shaped motion.

Because the size of channels is variable throughout the GI tract, aconstant size threading may not fit certain channels. For example, ifthe capsule diameter is too small compared to the channel diameter,there may not be sufficient tension to grip the capsule (see e.g., topimage of FIG. 26), whereas if the capsule diameter is too large comparedto the channel diameter, the capsule may get stuck in the channel.Accordingly, an optimal propulsive force depends on an optimal fitbetween the capsule endoscope 100 and the surrounding channel. To thatend, buoy 102 may be inflated to an optimal diameter, tension, and/orpressure, relative to the channel, so that the channel may exert amaximal propulsive force on the capsule (see e.g., bottom image of FIG.26). In one embodiment, inflation device 112 may inflate inflation buoy102 to a diameter that substantially matches (or is slightly, e.g.,5-20%, larger than) a channel diameter and/or to achieve a targetpressure between capsule endoscope 100 and the channel to propel theendoscope regardless of channel diameter. The target or optimaldiameter, tension, pressure, may be detected automatically (e.g., via apressure gauge connected to the inflation device 112) or manually.

Additionally or alternatively, inflating buoy 102 in narrow channels(e.g., having the same or smaller diameter than the capsule) may widenthe channel to increase the effective field of view of the sensingdevice. Reference is made to FIGS. 23-24, which schematically illustratean inflatable in-vivo capsule endoscope 100 in an uninflated state (FIG.23) and an inflated state (FIG. 24), according to an embodiment of theinvention. In FIG. 23, when the capsule endoscope 100 is in anuninflated state, narrow channel walls may obstruct the effective fieldof view (e.g., the visible space) of the organism to be significantlyless than the sensing device's 128 angle of view. In FIG. 24, when thecapsule endoscope 100 is in an inflated state, the channel walls arewidened to significantly increase the sensing device's 128 effectivefield of view.

Reference is made to FIG. 28, which schematically illustrates amagnetically releasable connection between tether 110 and in-vivocapsule endoscope 100, according to an embodiment of the invention.Tether 110 may have a magnetically releasable end 118 fitted andconnected to an end 106 of capsule endoscope 100. Magneticallyreleasable tether end 118 may have one or more invertible magnets havingan invertible magnetic dipole oriented in a first direction at rest(absent a non-constant external magnetic field) (see e.g., up-arrow inthe top image of FIG. 28). Capsule endoscope 100 has a permanent magnet124 having a permanent magnetic dipole oriented in a second fixeddirection (see e.g., down-arrow in the top image of FIG. 28). Tether's110 first magnetic dipole direction may be substantially opposite (andequal) to capsule's 100 second magnetic dipole direction (absent anexternal magnetic field) to cause a magnetic attraction and connectionbetween tether 110 and capsule endoscope 100. Tether's attachment end118 may fit or inter-lock with capsule's attachment end 106, forexample, by a concave/convex fitting (as shown in FIG. 28), flatfitting, lock and key fitting, or other fitting.

Tether 110 may be magnetically released from capsule endoscope 100 byexposure to an externally generated magnetic field (e.g., generated bythe external magnetic control system of FIG. 5 or by a hand-held magnetsufficiently close to the capsule endoscope) that flips or invertstether's invertible magnet so that its first magnetic dipole directioninverts (see e.g., up-arrow in top image flipped to down-arrow in secondimage in FIG. 28). Tether's inverted first magnetic dipole direction nowaligns with the capsule's first magnetic dipole direction. This causes arepulsive magnetic force between magnets in capsule's end 106 andtether's end 118 so that the tether and capsule repel each other andseparate.

In some embodiments, before or after the capsule is detached, tether 110may inject or expel liquid into the organism's body. In one embodiment,tether 110 may collect samples of body fluids e.g., by drawing liquidvia suction from the organism. In some cavities (e.g., the small bowel),too much or too little material makes it difficult for capsule endoscope100 to move. Accordingly, inflation device may inject liquid (e.g.,water or saline) or air via tether 110 into the cavity to inflate thecavity. Once inflated, the capsule may have more space for a betterfield of view, and/or reduced friction to make magnetic guidance easier.

Reference is made to FIG. 29, which schematically illustrates anautonomous (untethered) system comprising an in-vivo buoy 102 and anin-vivo inflation device 112, according to an embodiment of theinvention. In the autonomous system, inflation device 112 may be a partof, permanently attached to, or integral to, in-vivo capsule endoscope100. Inflation device 112 may be positioned in-vivo or inside of theorganism with the inflatable buoy 102 during inflation. In-vivoinflation device 112 may autonomously activate an in-vivo chemicalreaction to generate and emit gas that inflates buoy 102 (e.g., withoutdirect physical or manual contact with, or gas originating from, outsideof the organism). In some embodiment, in-vivo inflation device 112 maybe remotely activated to inflate/deflate buoy 102 via wirelesscommunication system 122. Additionally or alternatively, in-vivoinflation device 112 may be locally activated in response to capsule 100detecting one or more time/environment/imager conditions, such thatin-vivo capsule endoscope 100 is autonomous and self-inflating and/orself-deflating (without remote control). In-vivo inflation device 112may be an air compressor, chemical gas reactor, or gas powder to mixwith water. In various embodiments, in-vivo inflation device 112 may behoused interior to the capsule-shaped body 104 (e.g., as shown in FIG.29) or exterior to the capsule-shaped body 104 (e.g., inside orphysically attached to buoy 102). In some embodiments in which inflationdevice 112 is housed interior to the capsule body 104, the capsule body104 may have a (re-sealable) hole or channel 120 to transport gas fromthe internal inflation device 112 to the external inflation buoy 102,e.g., as shown in FIGS. 30 and 32. In some embodiments, in whichinflation device 112 is housed exterior to the capsule body 104, theinflation device is affixed to the inflation buoy 102 itself.

Reference is made to FIGS. 33-43, which schematically illustrate aninflatable in-vivo capsule endoscope that is bi-directional with adual-camera or two-sided imager to capture images in either forwardand/or reverse axial direction, according to various embodiments of theinvention.

Reference is made to FIG. 33, which schematically illustrates anexploded view of a bi-directional in-vivo capsule endoscope 100 with atwo-sided sensing device 128, e.g., housed internal to capsule-shapedbody 104, according to an embodiment of the invention. Capsule-shapedbody 104 may have a longitudinal axis 111 along its longest length and aradial axis 121 along a diameter of its circular cross-section.Capsule-shaped body 104 may have two concave end shells or hemispheres106 and 108 at opposite ends of its longitudinal axis 111, and a middle(e.g., cylindrical-shaped) shell 109 joining end shells 106 and 108 atthe center of its longitudinal axis 111. As capsule endoscope 100 isbi-directional, it has a dual or two-sided imager or sensing device 128at opposite ends of its longitudinal axis 111 to capture images ineither forward and/or reverse directions along its longitudinal axis111. Both end shells 106 and 108 comprise transparent windows forhousing the two sensing devices 128. Bi-directional capsule endoscope100 may comprise other components as described in reference to FIGS. 4and/or 22.

Reference is made to FIGS. 34-38 and 40-43, which are schematicillustrations of an in-vivo buoy 102 adapted to encapsulate abi-directional in-vivo capsule endoscope 100, according to variousembodiments of the invention. To encapsulate a bi-directional in-vivocapsule endoscope 100, in-vivo buoy 102 may not cover (or maytransparently cover) the two opposite longitudinal end shells orhemispheres 106 or 108 of the endoscope 100. Since buoy 102 does notobscure either end, the two sensing devices 128 of bi-directionalendoscope 100 have unobstructed fields of view (FOV), e.g., as shown inreference to FIGS. 36 and 38. Bi-directional endoscope buoy 102 may havevarious sizes and shapes, such as, torus-shaped (when inflated) andcylindrical-shaped (when deflated), spherical, ellipsoidal, etc.

In FIGS. 34-38, bi-directional endoscope buoy 102 is connected via anelongated tether 110 to an external inflation device 112.

In FIG. 34, the bi-directional endoscope buoy 102 is connected to thetether 110, and in FIG. 35, the tethered assembly 102 and 110encapsulates the center trunk (middle shell 109) of the bi-directionalin-vivo capsule endoscope 100.

The inflatable bi-directional in-vivo capsule endoscope 100 encapsulatedby the tethered in-vivo buoy 102 is positioned in a cavity of anorganism in an uninflated state (FIGS. 34-36) and in an inflated state(FIGS. 37-38). The inflation device 112 may inject liquid (e.g., wateror saline) or air via tether 110 into the cavity of buoy 102 to inflatethe cavity. Once inflated in FIG. 38, the capsule 100 may float abovethe cavity floor, to reduce or eliminate obstructions or occlusions bythe cavity walls or floor to one or both of the two sensing devices ofthe bi-directional endoscope. Accordingly, the sensing devices may havebetter fields of view (FOV).

In FIGS. 39-43, bi-directional endoscope is autonomous (untethered) andcontains an internal inflation device 112 to inflate buoy 102.

Reference is made to FIG. 39, which schematically illustrates anexploded view of an autonomous (untethered) bi-directional in-vivocapsule endoscope 100 comprising an internal inflation device 112,according to an embodiment of the invention. In the autonomous system,inflation device 112 may be a part of, permanently attached to, orintegral to, in-vivo capsule endoscope 100 and may operate as describedin reference to FIGS. 29-32. Inflation device 112 may be positionedin-vivo or inside of the organism with the inflatable buoy 102 duringinflation. In-vivo inflation device 112 may autonomously activate anin-vivo chemical reaction to generate and emit gas that inflates buoy102. In some embodiments, gas generated by interior inflation device 112is transported via a (re-sealable) hole or channel 120 to inflateinflation buoy 102, e.g., as shown in FIGS. 41 and 43.

Reference is made to FIGS. 40-41, which schematically illustrate theautonomous bi-directional in-vivo capsule endoscope that is inflatableby a “cup expansion” type buoy, according to an embodiment of theinvention.

Reference is made to FIGS. 42 and 43, which schematically illustrate theautonomous inflatable bi-directional in-vivo capsule endoscope 100 in acavity of an organism in an uninflated state (FIG. 42) and an inflatedstate (FIG. 43), according to an embodiment of the invention. Theinternal inflation device 112 may autonomously activate an in-vivochemical reaction to generate and emit gas via a hole 120 into thecavity of buoy 102 to inflate the cavity. Once inflated in FIG. 42, thecapsule 100 floats above the cavity floor, to reduce or eliminateobstructions and improve the visibility and effective field of view ofone or both of the two sensing devices of the bi-directional endoscope100.

Reference is made to FIG. 44, which is a flowchart of a method ofoperating an inflatable in-vivo capsule endoscope, according to anembodiment of the invention. The operations of FIG. 44 may be executedusing the inflatable in-vivo capsule endoscope disclosed in reference toone or more of FIGS. 1-43.

In operation 1000, an inflatable in-vivo capsule endoscope (e.g., 100 ofFIGS. 1-4, 6, 8, 10-18, 20-26, 28-33, and 35-43) may be introduced in anuninflated state into a cavity comprising liquid inside an organism (seee.g., FIG. 2). The capsule endoscope may comprise a capsule-shaped body(e.g., 104), an inflatable buoy (e.g., 102) external to thecapsule-shaped body, and a sensing device (e.g., 128) for capturingin-vivo images housed interior to the capsule-shaped body.

In operation 1002, an inflation device (e.g., 112) may be activated toinflate the inflatable buoy by injecting an above threshold volume ofgas into the inflatable buoy to reduce the specific gravity of thein-vivo capsule endoscope, such that, the inflatable in-vivo capsuleendoscope floats in the liquid cavity. In one embodiment, the inflatablein-vivo capsule endoscope may float based only on buoyancy, e.g., byinjecting a volume of gas such that the density of the in-vivo capsuleendoscope is less than or equal to the density of water. In anotherembodiment, the inflatable in-vivo capsule endoscope may float based ona combination of injecting a volume of gas and magnetically lifting thecapsule by exposure to an externally generated magnetic field. Theinflation/deflation device may inject or expel gas to a desired volumeor pressure to tune the flotation height level of the inflatable in-vivocapsule endoscope relative to the height level of the liquid.

In some embodiments, a tethered system may be used (see e.g., FIGS. 2-3,6-21, 23-26, 28 and 34-38). In a tethered system, the inflation devicemay be an ex-vivo inflation device positioned outside of an organismwhen inflating the in-vivo inflatable buoy positioned inside of theorganism. The ex-vivo inflation device may be attached to the buoy by anelongated tether (e.g., 110) that traverses at least a portion of theorganism (see e.g., FIG. 6). The tether may be magnetically attached toor released from the capsule-shaped body (see e.g., FIG. 28). The tethermay be used to draw liquid to collect body fluids from the organism.

In some embodiments, an autonomous (untethered) system may be used (seee.g., FIGS. 29-32 and 39-43). In an autonomous (untethered) system, theinflation device may be an in-vivo inflation device that is permanentlyattached to the capsule-shaped body and positioned inside of theorganism with the inflatable buoy during inflation. The in-vivoinflation device may autonomously generate the gas by a chemicalreaction in the in-vivo inflation device.

In some embodiment, the inflation buoy may be positioned asymmetricallyrelative to a radial axis of the capsule body, such that thecapsule-shaped body is oriented by inflating the asymmetricallypositioned inflation buoy (e.g., the buoy rises to the top) (see e.g.,FIGS. 15-18). In one embodiment, the capsule-shaped body is orientedlevel with its longitudinal axis (see e.g., FIGS. 15-16). In anotherembodiment, the capsule-shaped body is oriented to direct the sensingdevice's field of view towards a targeted area (see e.g., FIGS. 17-18).In some embodiment, the capsule endoscope is bi-directional having twosensing devices oriented in opposite directions (see e.g., FIGS. 33-43).

In operation 1004, the floating in-vivo capsule endoscope may bemagnetically navigated by exposing one or more permanent magnets (e.g.,124) housed interior to the capsule-shaped body having a permanentmagnetic dipole moment to an externally generated magnetic field thatmagnetically guides the inflatable in-vivo capsule endoscope. Anexternal magnetic control system (e.g., 126 of FIG. 5) may be operatedto generate the magnetic field. The externally generated magnetic fieldmay be operated at a significantly weaker intensity for magneticallyguiding a capsule floating in liquid (e.g., approximately 75 A/cm²), andthus may be generated using a significantly smaller external magnet,than is used to guide a conventional (uninflated) capsule (e.g.,approximately 2500 A/cm²).

In some embodiments, the inflation buoy has a corkscrew-shaped surface(see e.g., FIGS. 19-27) such that the inflatable in-vivo capsuleendoscope rotates in a spiral motion when it is magnetically navigatedthorough a channel. The inflatable in-vivo capsule endoscope may propelforward when the corkscrew-shaped surface rotates in a first directionand backwards when the corkscrew-shaped surface rotates in an oppositedirection. The inflation buoy may be inflated to a diameter thatsubstantially matches a channel diameter to achieve a target pressurebetween the endoscope and the channel. The in-vivo capsule endoscope maybe magnetically rotated about its longitudinal axis to propel thecorkscrew-shaped surface.

In operation 1006, an deflation device (e.g., 112 or another device) maybe activated to deflate the inflatable buoy by expelling gas such thatthe inflatable in-vivo capsule endoscope sinks in the liquid cavity.Once the in-vivo capsule endoscope is partially or fully uninflated, itcan be either retracted backwards through the esophagus via a tether ordetached and guided forward to progress autonomously through theremainder of the GI tract.

A method is provided for manufacturing or assembling the components orparts of the inflatable in-vivo capsule endoscope 100 shown in FIGS.1-4, 6, 8, 10-18, 20-26, 28-33 and/or 35-43.

Embodiments of the invention provide capsule endoscope 100 with aninflatable buoy 102 to examine areas of the GI tract, such as, theesophagus and stomach. Capsule endoscope may be tethered by an elongatedtube, which may be volume adjustable and expandable by controlling theinjection/disposal of gas. When the capsule endoscope is in liquid in acavity, the volume adjustable expanded tube can provide an additionalfloating force to the capsule endoscope. Combined with the externalmagnetic control, the capsule endoscope is easier to move inside thewater. While in channels, such as the small bowl, the volume adjustablebuoy expands in a spiral-shaped structure to further move in esophagusor in small bowl by the aid of external magnetic control.

Buoy expansion can adjust the effective specific gravity of capsule inwater thus changing the float force. This method can reduce the magneticinduction intensity requirement of external magnetic field duringcapsule inspection for position and orientation change of the capsule.The external magnetic field intensity used to control the capsuleendoscope whose specific gravity is greater than water, is greater thanthe capsule whose specific gravity is less than or equal to water. Thebuoy membrane may be glued to form a bladder. The gravitational centerlocation vs. the geometry center changes the posture of the capsule whenthe bladder is injected with air. This will help to achieve differentangles of observation by injecting different amounts of air, as well asby magnetic guidance. After the digestive tract examination iscompleted, the air in the balloon may be withdrawn, so that the volumeof the capsule body is minimized, and the entire capsule is pulled backfrom the mouth by the tether, or detached from the tether and allowed toproceed autonomously through the remainder of the digestive tract.

Although embodiments of the invention describe inflating a buoy externalto the capsule body, the buoy may also be disposed internal to thecapsule body or may be the capsule body itself, where the capsule bodyis expandable, elastic or deformable.

Although the application describes inflating the buoy with a gas, thebuoy may also be inflated with other materials, such as, foam, oil, orother gaseous or liquid substances or mixtures that have a lower densitythan water. The matter may be supplied by the buoy itself, a reservoirinternal to the capsule body via an internal channel, or may be absorbedfrom the capsule's ambient environment in the organism's cavity via anexternal channel.

The principles of the invention shown and described may also be appliedto additional uses in vivo or to probes used in other contexts such asmechanical or fluid-handling systems. The term “capsule” may be usedinterchangeably with the term “probe” herein to refer to probe apparatusand similar remote objects in general, regardless of shape. It should beunderstood that a capsule may be spherical, ellipsoidal, cylindricalwith two half-domes, or other suitable shapes or combinations of shapes.In FIG. 1, the magnetic capsule has a length, which is the longestdimension of the capsule. The length direction is referred as alongitude direction or axis 111 of the capsule. The magnetic capsuledoes not have to have a cylinder shape having one or two half domed endsas shown in FIG. 1. The capsule can be of any shape and weight as longas the fundamental physical principal is applicable to the magneticcapsule.

The capsule has a magnetic dipole direction, which is parallel to thecapsule longitudinal axis 111, either forward or backward. The capsulemay thus be magnetically guided to move linearly, such that, themovement direction is the same as, coincide, or parallel as thelongitude direction of the capsule. In some embodiments, the capsule hasa magnetic dipole direction that is asymmetrical relative to its radialaxis 121, which together or separate from the spiral exterior surface orbuoy, causes the capsule to be magnetically guided to rotate about itslongitudinal axis, thereby moving in a spiral or a corkscrew motion.This corkscrew motion may aid in propulsion forwards or backwards, e.g.,through channels of the GI tract. The capsule moves forward may meanthat the capsule progresses along the tract farther away from the mouthor entry point. The capsule moves backward may mean that the capsulemoves along the tract towards and closer to the mouth or entry point.The front end, in one example, comprising a diagnostic sensor ortherapeutic device, such as a camera. The back end, which may belinearly opposite to the front end, can also include a complimentarydiagnostic sensor or therapeutic device, or may simply comprise a shell.

Although capsule endoscope is shown to be located in specific cavities,such as, a stomach in FIGS. 2 and 3, this is only an example, and anyother cavity or organism may be used.

For simplicity purpose, capsule endoscope 100 is described in thecontext of biomedical applications, i.e. the target location is an invivo location, for example a location inside a digestive tract. Forsimplicity purpose, the medical device disclosed herein is designed tobe placed in vivo. One of the non-invasive methods of delivery is byswallow into a digestive tract. Therefore, the medical device disclosedherein is referred as a capsule, which should not be construed as alimitation for its shape, dimension or size. The capsule devicedisclosed herein and methods of using the same can be implemented formany other applications beyond biomedical applications.

Various embodiments of the invention include:

-   -   1. An inflatable in-vivo capsule endoscope comprising:        -   a capsule-shaped body;        -   a sensing device for capturing in-vivo images housed            interior to the capsule-shaped body;        -   an inflatable buoy external to the capsule-shaped body;        -   an inflation device configured to inflate the in-vivo            capsule endoscope by injecting gas into the inflatable buoy            to reduce the specific gravity of the in-vivo capsule            endoscope, such that when the inflatable buoy is injected            with an above threshold volume of gas, the inflatable            in-vivo capsule endoscope is configured to float in liquid;            and        -   one or more permanent magnets housed interior to the            capsule-shaped body having a permanent magnetic moment for            magnetically guiding the inflatable in-vivo capsule            endoscope when exposed to an externally generated magnetic            field.    -   2. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation device injects a volume of gas such that the density        of the in-vivo capsule endoscope is less than or equal to the        density of water.    -   3. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation device injects a volume of gas such that the density        of the in-vivo capsule endoscope is greater than the density of        water by an amount counteracted by a magnetic lift force.    -   4. The inflatable in-vivo capsule endoscope of 1, comprising a        deflation device configured to increase the specific gravity of        the in-vivo capsule endoscope by expelling gas, such that when        the inflatable buoy has a below threshold volume of gas, the        inflatable in-vivo capsule endoscope sinks in liquid.    -   5. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation device injects or expels gas to a desired volume or        pressure to tune the flotation height level of the inflatable        in-vivo capsule endoscope relative to the height level of the        liquid.    -   6. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation buoy has a corkscrew-shaped surface when inflated to        propel the inflatable in-vivo capsule endoscope forward by        rotating in a spiral motion.    -   7. The inflatable in-vivo capsule endoscope of 6, wherein the        corkscrew-shaped surface propels the inflatable in-vivo capsule        endoscope forward when rotating in a first direction and        backwards when rotating in an opposite direction.    -   8. The inflatable in-vivo capsule endoscope of 6, wherein the        inflation device inflates the inflation buoy to a diameter that        substantially matches a channel diameter to achieve a target        pressure between the endoscope and the channel to propel the        endoscope regardless of channel diameter.    -   9. The inflatable in-vivo capsule endoscope of 6, wherein the        permanent magnets are radially spaced from the center of mass        with respect to a radial axis of the capsule-shaped body to        cause an asymmetric spiraling force for propelling the        corkscrew-shaped surface when exposed to the externally        generated magnetic field.    -   10. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation device is an ex-vivo device that is positioned outside        of an organism when inflating the in-vivo inflatable buoy        positioned inside of the organism.    -   11. The inflatable in-vivo capsule endoscope of 10, wherein the        ex-vivo inflation device is attached to the buoy by an elongated        tether that traverses at least a portion of the GI tract of the        organism.    -   12. The inflatable in-vivo capsule endoscope of 11, wherein the        tether is magnetically attached to the capsule-shaped body.    -   13. The inflatable in-vivo capsule endoscope of 12, wherein the        tether is magnetically separable from the capsule-shaped body by        exposure to an externally generated magnetic field causing a        repulsive magnetic force between magnets in the tether and the        capsule-shaped body.    -   14. The inflatable in-vivo capsule endoscope of 10, wherein the        external inflation device is a syringe.    -   15. The inflatable in-vivo capsule endoscope of 10, wherein the        external inflation device is a pump.    -   16. The inflatable in-vivo capsule endoscope of 10, wherein the        tether is configured to draw liquid for collecting body fluids        from the organism.    -   17. The inflatable in-vivo capsule endoscope of 1, wherein the        inflation device is an in-vivo device permanently attached to        the capsule-shaped body that is positioned inside of the        organism with the inflatable buoy during inflation.    -   18. The inflatable in-vivo capsule endoscope of 17, wherein the        inflation device autonomously generates the gas by a chemical        reaction.    -   19. The inflatable in-vivo capsule endoscope of 17, wherein the        in-vivo inflation device is housed interior to the        capsule-shaped body and the body has a hole to transport the gas        from the internal inflation device to the external inflation        buoy.    -   20. The inflatable in-vivo capsule endoscope of 17, wherein the        inflation device is affixed to the inflation buoy external to        the capsule-shaped body.    -   21. The inflatable in-vivo capsule endoscope of 17, wherein the        inflation buoy is positioned asymmetrically relative to a radial        axis of the capsule body, such that the inflation buoy rises to        a relatively higher liquid level to rotationally orient the        capsule-shaped body.    -   22. The inflatable in-vivo capsule endoscope of 1, comprising an        external magnetic control system to generate the externally        generated magnetic field.    -   23. The inflatable in-vivo capsule endoscope of 1, wherein the        inflatable buoy encapsulated the portion of the capsule-shaped        body outside of the field of view of the sensing device.    -   24. The inflatable in-vivo capsule endoscope of 1 comprising a        one-sided sensing device encapsulated by a concave inner surface        of the inflation buoy.    -   25. The inflatable in-vivo capsule endoscope of 1 comprising a        two-sided sensing device encapsulated by a cylindrical inner        surface of the inflation buoy.    -   26. A method of operating an inflatable in-vivo capsule        endoscope, the method comprising:        -   introducing an inflatable in-vivo capsule endoscope in an            uninflated state into a cavity comprising liquid inside an            organism, said capsule endoscope comprising a capsule-shaped            body, an inflatable buoy external to the capsule-shaped            body, and a sensing device for capturing in-vivo images            housed interior to the capsule-shaped body;        -   activating an inflation device to inflate the inflatable            buoy by injecting an above threshold volume of gas into the            inflatable buoy to reduce the specific gravity of the            in-vivo capsule endoscope, such that, the inflatable in-vivo            capsule endoscope floats in the liquid cavity; and        -   magnetically navigating the floating in-vivo capsule            endoscope by exposing one or more permanent magnets housed            interior to the capsule-shaped body having a permanent            magnetic dipole moment to an externally generated magnetic            field that magnetically guides the inflatable in-vivo            capsule endoscope.    -   27. The method of 26 comprising causing the inflatable in-vivo        capsule endoscope to float by injecting a volume of gas such        that the density of the in-vivo capsule endoscope is less than        or equal to the density of water.    -   28. The method of 26 comprising causing the inflatable in-vivo        capsule endoscope to float by a combination of injecting a        volume of gas and magnetically lifting the capsule by exposure        to an externally generated magnetic field.    -   29. The method of 26 comprising deflating the inflatable buoy by        expelling gas such that the inflatable in-vivo capsule endoscope        sinks in liquid.    -   30. The method of 26 comprising injecting or expelling gas to a        desired volume or pressure to tune the flotation height level of        the inflatable in-vivo capsule endoscope relative to the height        level of the liquid.    -   31. The method of 26, wherein the inflation buoy has a        corkscrew-shaped surface such that the inflatable in-vivo        capsule endoscope rotates in a spiral motion when it is        magnetically navigated thorough a channel.    -   32. The method of 31 comprising propelling the inflatable        in-vivo capsule endoscope forward when the corkscrew-shaped        surface rotates in a first direction and backwards when the        corkscrew-shaped surface rotates in an opposite direction.    -   33. The method of 31 comprising inflating the inflation buoy to        a diameter that substantially matches a channel diameter to        achieve a target pressure between the endoscope and the channel.    -   34. The method of 31 comprising magnetically rotating the        in-vivo capsule endoscope about its longitudinal axis to propel        the corkscrew-shaped surface.    -   35. The method of 26 comprising activating an ex-vivo inflation        device positioned outside of an organism when inflating the        in-vivo inflatable buoy positioned inside of the organism,        wherein the ex-vivo inflation device is attached to the buoy by        an elongated tether that traverses at least a portion of the        organism.    -   36. The method of 35 comprising magnetically attaching or        releasing the tether to or from the capsule-shaped body.    -   37. The method of 35 comprising drawing liquid through the        tether to collect body fluids from the organism.    -   38. The method of 26 comprising activating an in-vivo inflation        device that is permanently attached to the capsule-shaped body        and positioned inside of the organism with the inflatable buoy        during inflation.    -   39. The method of 38 comprising autonomously generating the gas        by a chemical reaction in the in-vivo inflation device.    -   40. The method of 26, wherein the inflation buoy is positioned        asymmetrically relative to a radial axis of the capsule body,        comprising orienting the capsule-shaped body by inflating the        asymmetrically positioned inflation buoy.    -   41. The method of 26 comprising generating the externally        generated magnetic field by operating an external magnetic        control system.    -   42. A method of manufacturing the inflatable in-vivo capsule        endoscope of any of 1-25.

In the foregoing description, various aspects of the present inventionare described. For purposes of explanation, specific configurations anddetails are set forth in order to provide a thorough understanding ofthe present invention. However, it will also be apparent to persons ofordinary skill in the art that the present invention may be practicedwithout the specific details presented herein. Furthermore, well knownfeatures may be omitted or simplified in order not to obscure thepresent invention.

Unless specifically stated otherwise, as apparent from the followingdiscussions, it is appreciated that throughout the specificationdiscussions utilizing terms such as “processing,” “computing,”“calculating,” “determining,” or the like, refer to the action and/orprocesses of a computer or computing system, or similar electroniccomputing device, that manipulates and/or transforms data represented asphysical, such as electronic, quantities within the computing system'sregisters and/or memories into other data similarly represented asphysical quantities within the computing system's memories, registers orother such information storage, transmission or display devices.

The aforementioned flowchart and block diagrams illustrate thearchitecture, functionality, and operation of possible implementationsof systems and methods according to various embodiments of the presentinvention. In this regard, each block in the flowchart or block diagramsmay represent a module, segment, or portion of code, which may compriseone or more executable instructions for implementing the specifiedlogical function(s). In some alternative implementations, the functionsnoted in the block may occur out of the order noted in the figures or bydifferent modules. Unless explicitly stated, the method embodimentsdescribed herein are not constrained to a particular order or sequence.Additionally, some of the described method embodiments or elementsthereof can occur or be performed at the same point in time. Each blockof the block diagrams and/or flowchart illustration, and combinations ofblocks in the block diagrams and/or flowchart illustration, can beimplemented by special purpose hardware-based systems that perform thespecified functions or acts, or combinations of special purpose hardwareand computer instructions.

Embodiments of the invention may include an article such as anon-transitory computer or processor readable medium, or a computer orprocessor non-transitory storage medium, such as for example a memory(e.g., memory units of processing board(s) in FIG. 4), a disk drive, ora USB flash memory, encoding, including or storing instructions, e.g.,computer-executable instructions, which, when executed by a processor orcontroller (e.g., processing board(s) in FIG. 4), carry out methodsdisclosed herein.

In the above description, an embodiment is an example or implementationof the inventions. The various appearances of “one embodiment,” “anembodiment” or “some embodiments” do not necessarily all refer to thesame embodiments. Although various features of the invention may bedescribed in the context of a single embodiment, the features ofembodiments may also be provided separately or in any suitablecombination. Conversely, although the invention may be described hereinin the context of separate embodiments for clarity, the invention mayalso be implemented in a single embodiment. Reference in thespecification to “some embodiments”, “an embodiment”, “one embodiment”or “other embodiments” means that a particular feature, structure, orcharacteristic described in connection with the embodiments is includedin at least some embodiments, but not necessarily all embodiments, ofthe inventions. It will further be recognized that the aspects of theinvention described hereinabove may be combined or otherwise coexist inembodiments of the invention.

The descriptions, examples, methods and materials presented in theclaims and the specification are not to be construed as limiting butrather as illustrative only. While certain features of the presentinvention have been illustrated and described herein, manymodifications, substitutions, changes, and equivalents may occur tothose of ordinary skill in the art. It is, therefore, to be understoodthat the appended claims are intended to cover all such modificationsand changes as fall with the true spirit of the invention.

While the invention has been described with respect to a limited numberof embodiments, these should not be construed as limitations on thescope of the invention, but rather as exemplifications of some of thepreferred embodiments. Other possible variations, modifications, andapplications are also within the scope of the invention. Differentembodiments are disclosed herein. Features of certain embodiments may becombined with features of other embodiments; thus certain embodimentsmay be combinations of features of multiple embodiments. Accordingly,the scope of the invention should not be limited by what has thus farbeen described, but by the appended claims and their legal equivalents.

1. An inflatable in-vivo capsule endoscope comprising: a capsule-shapedbody; a sensing device for capturing in-vivo images housed interior tothe capsule-shaped body; an inflatable buoy external to thecapsule-shaped body; an inflation device configured to inflate thein-vivo capsule endoscope by injecting gas into the inflatable buoy toreduce the specific gravity of the in-vivo capsule endoscope, such thatwhen the inflatable buoy is injected with an above threshold volume ofgas, the inflatable in-vivo capsule endoscope is configured to float inliquid; and one or more permanent magnets housed interior to thecapsule-shaped body having a permanent magnetic moment for magneticallyguiding the inflatable in-vivo capsule endoscope when exposed to anexternally generated magnetic field.
 2. The inflatable in-vivo capsuleendoscope of 1, wherein the inflation device injects a volume of gassuch that the density of the in-vivo capsule endoscope is less than orequal to the density of water.
 3. The inflatable in-vivo capsuleendoscope of 1, wherein the inflation device injects a volume of gassuch that the density of the in-vivo capsule endoscope is greater thanthe density of water by an amount counteracted by a magnetic lift force.4. The inflatable in-vivo capsule endoscope of 1, comprising a deflationdevice configured to increase the specific gravity of the in-vivocapsule endoscope by expelling gas, such that when the inflatable buoyhas a below threshold volume of gas, the inflatable in-vivo capsuleendoscope sinks in liquid.
 5. The inflatable in-vivo capsule endoscopeof 1, wherein the inflation device injects or expels gas to a desiredvolume or pressure to tune the flotation height level of the inflatablein-vivo capsule endoscope relative to the height level of the liquid. 6.The inflatable in-vivo capsule endoscope of 1, wherein thecapsule-shaped body comprises a first magnetic dipole and the inflatablebuoy comprises a second magnetic dipole, wherein the first and secondmagnetic dipoles are oriented in opposite directions absent a predefinedmagnetic field to cause a magnetic attraction and connection between theinflatable buoy and the capsule-shaped body, and wherein one of thefirst or second magnetic dipoles is configured to invert when exposed tothe predefined magnetic field, such that the first and second magneticdipoles are oriented in substantially the same direction to cause amagnetic repulsion and release between the inflatable buoy and thecapsule-shaped body.
 7. The inflatable in-vivo capsule endoscope of 1,wherein the inflation buoy has a corkscrew-shaped surface when inflatedto propel the inflatable in-vivo capsule endoscope forward by rotatingin a spiral motion.
 8. The inflatable in-vivo capsule endoscope of 7,wherein the corkscrew-shaped surface propels the inflatable in-vivocapsule endoscope forward when rotating in a first direction andbackwards when rotating in an opposite direction.
 9. The inflatablein-vivo capsule endoscope of 7, wherein the inflation device inflatesthe inflation buoy to a diameter that substantially matches a channeldiameter to achieve a target pressure between the endoscope and thechannel to propel the endoscope regardless of channel diameter.
 10. Theinflatable in-vivo capsule endoscope of 7, wherein the permanent magnetsare radially spaced from the center of mass with respect to a radialaxis of the capsule-shaped body to cause an asymmetric spiraling forcefor propelling the corkscrew-shaped surface when exposed to theexternally generated magnetic field.
 11. The inflatable in-vivo capsuleendoscope of 1, wherein the inflation device is an ex-vivo device thatis positioned outside of an organism when inflating the in-vivoinflatable buoy positioned inside of the organism and attached to thebuoy by an elongated tether that traverses at least a portion of the GItract of the organism.
 12. The inflatable in-vivo capsule endoscope of11, wherein the external inflation device is a syringe or pump.
 13. Theinflatable in-vivo capsule endoscope of 1, wherein the inflation deviceis an in-vivo device permanently attached to the capsule-shaped bodythat is positioned inside of the organism with the inflatable buoyduring inflation, wherein the inflation device autonomously generatesgas by a chemical reaction.
 14. The inflatable in-vivo capsule endoscopeof 13, wherein the in-vivo inflation device is housed interior to thecapsule-shaped body and the body has a hole to transport the gas fromthe internal inflation device to the external inflation buoy.
 15. Theinflatable in-vivo capsule endoscope of 13, wherein the inflation deviceis affixed to the inflation buoy external to the capsule-shaped body.16. The inflatable in-vivo capsule endoscope of 13, wherein theinflation buoy is positioned asymmetrically relative to a radial axis ofthe capsule body, such that the inflation buoy rises to a relativelyhigher liquid level to rotationally orient the capsule-shaped body. 17.The inflatable in-vivo capsule endoscope of 1, wherein the inflatablebuoy encapsulated the portion of the capsule-shaped body outside of thefield of view of the sensing device.
 18. The inflatable in-vivo capsuleendoscope of 1 comprising a one-sided sensing device encapsulated by aconcave inner surface of the inflation buoy.
 19. The inflatable in-vivocapsule endoscope of 1 comprising a two-sided sensing deviceencapsulated by a cylindrical inner surface of the inflation buoy.
 20. Asystem comprising the inflatable in-vivo capsule endoscope of 1 and anexternal magnetic control system to generate the externally generatedmagnetic field for magnetically guiding the inflatable in-vivo capsuleendoscope.
 21. A method of operating an inflatable in-vivo capsuleendoscope, the method comprising: introducing an inflatable in-vivocapsule endoscope in an uninflated state into a cavity comprising liquidinside an organism, said capsule endoscope comprising a capsule-shapedbody, an inflatable buoy external to the capsule-shaped body, and asensing device for capturing in-vivo images housed interior to thecapsule-shaped body; activating an inflation device to inflate theinflatable buoy by injecting an above threshold volume of gas into theinflatable buoy to reduce the specific gravity of the in-vivo capsuleendoscope, such that, the inflatable in-vivo capsule endoscope floats inthe liquid cavity; and magnetically navigating the floating in-vivocapsule endoscope by exposing one or more permanent magnets housedinterior to the capsule-shaped body having a permanent magnetic dipolemoment to an externally generated magnetic field that magneticallyguides the inflatable in-vivo capsule endoscope.
 22. The method of 21comprising causing the inflatable in-vivo capsule endoscope to float byinjecting a volume of gas such that the density of the in-vivo capsuleendoscope is less than or equal to the density of water.
 23. The methodof 21 comprising causing the inflatable in-vivo capsule endoscope tofloat by a combination of injecting a volume of gas and magneticallylifting the capsule by exposure to an externally generated magneticfield.
 24. The method of 21 comprising deflating the inflatable buoy byexpelling gas such that the inflatable in-vivo capsule endoscope sinksin liquid.
 25. The method of 21 comprising injecting or expelling gas toa desired volume or pressure to tune the flotation height level of theinflatable in-vivo capsule endoscope relative to the height level of theliquid.
 26. The method of 21, wherein the inflation buoy has acorkscrew-shaped surface such that the inflatable in-vivo capsuleendoscope rotates in a spiral motion when it is magnetically navigatedthorough a channel.
 27. The method of 26 comprising magneticallyrotating the in-vivo capsule endoscope about its longitudinal axis topropel the corkscrew-shaped surface.
 28. The method of 21 comprisingactivating an ex-vivo inflation device positioned outside of an organismwhen inflating the in-vivo inflatable buoy positioned inside of theorganism, wherein the ex-vivo inflation device is attached to the buoyby an elongated tether that traverses at least a portion of theorganism.
 29. The method of 21 comprising activating an in-vivoinflation device that is permanently attached to the capsule-shaped bodyand positioned inside of the organism with the inflatable buoy duringinflation, wherein activating the in-vivo inflation device comprisesautonomously generating gas by a chemical reaction.
 30. The method of21, wherein the inflation buoy is positioned asymmetrically relative toa radial axis of the capsule body, comprising orienting thecapsule-shaped body by inflating the asymmetrically positioned inflationbuoy.